MAUDE Adverse Event Report: HILLROM DE MEXICO S DE RL DE CV TRANSTAR STRETCHER; WHEELED STRETCHER

Model Number 8000

Device Problem Component Missing (2306)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/26/2014

Event Type  malfunction  

Event Description

The account reported the side rail end tube is missing the ratchet rivets.The stretcher is located in the emergency room at the facility.There was no patient/user injury reported.This report was filed in our complaint handling system as complaint # (b)(4).

Manufacturer Narrative

The technician found the side rail would not latch in the upright position due to the ratchet rivets that secure the end tube to the top of the rail were missing.The account stated the ratchet rivets were knocked out during transport most likely due to force such as the stretcher being ran into an object.A search of the hill-rom maintenance records showed hill-rom performed preventative maintenance on this bed in 2007 through 2013.It is unknown if the facility performed any other preventative maintenance on this bed.The ratchet rivets were replaced by the technician to resolve the issue.Based on this info, no further action is required.

• Brand Name: TRANSTAR STRETCHER
• Type of Device: WHEELED STRETCHER
• Manufacturer (Section D): HILLROM DE MEXICO S DE RL DE CV; apodaca ; MX
• Manufacturer Contact: jennifer morris ; 1069 state route 46 east; batesville, IN 47006 ; 8129313121
• MDR Report Key: 3941059
• MDR Text Key: 4573066
• Report Number: 3006697241-2014-00400
• Device Sequence Number: 1
• Product Code: FPO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 03/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 8000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/26/2014
• Initial Date FDA Received: 04/24/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2004
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1